Cytotoxicity Testing- ISO 10993-5

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

Medical devices that have direct or indirect contact with the body tissue is an important quality issue relating to the biocompatibility of the product. According to ISO 10993-1 the biocompatibility of products must be tested before being brought to market (CE-certification).

Catheters, Inhalators, Implants, wound dressings and a various other Medical Device products must meet or exceed the highest quality standards possible to ensure perfect functioning of a product.

A critical in vitro test in medical device biocompatibility testing is the cytotoxicity test according to ISO 10993-5. In this type of test mammalian cells are cultivated with direct contact to the medical device materials or material extract of the medical device is pipetted onto the precultivated mice cells to test the cell vitality.

At Whitehouse Laboratories Cytotoxicity we provide testing services that are cost-effective, quickly performed, reliable and furnish data results.

Cytotoxicity Testing – ISO 10993-5:

  • Evaluating the impact of sterilization, packaging und material surface treatment processes on the biocompatibility products
  • Batch Testing during the course of medical device production
  • For CE-certification of a medical device
  • Testing of product quality of a supplier
  • Comparative testing of biocompatibility of a competitor product

 

Ethylene Oxide Residual Testing – ISO 10993-7

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Ethylene oxide is commonly used as a sterilant causing companies to show evidence that (ETO) ethylene oxide and its common degradants (ECH) ethylene chlorohydrin and (EG) ethylene glycol do not exist in the product and packaging. Ethylene oxide is normally chosen because it is effective and will not adversely affect the materials used to manufacture medical devices.

Whitehouse Laboratories provides analytical ethylene oxide residual testing of terminally sterilized medical devices using currently accepted Gas Chromatography (GC) methods:

  • Gas Chromatography water extracts for ethylene oxide (ETO)
  • Gas Chromatography water extracts for ethylene glycol (EG) and ethylene chlorohydrin (ECH)
  • Gas Chromatography with Solid-Phase Micro Extraction
  • Gas Chromatography using headspace sampling for ethylene oxide (ETO

Whitehouse Laboratories performs ethylene oxide residual testing in compliance with the guidelines provided by ANSI/AAMI/ISO 10993-7. The evaluation of any device prior to testing is critical in deciding how all testing will be conducted.